PMA P000025S096
- Device
- Combi 40+ Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S096
- Product code
- MCM
- Decision date
- 2017-07-12
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Addition of a second source supplier for the hybrid assembly of the Mi1200 SYNCHRONY Cochlear Implant.
Current openFDA PMA Record#
- Device
- Combi 40+ Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S096
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2017-07-12
- Decision code
- OK30
- Date received
- 2017-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a second source supplier for the hybrid assembly of the Mi1200 SYNCHRONY Cochlear Implant.